Institutional Review Board

Objective

The IRB of the International Vaccine Institute is an appropriately constituted administrative body established to protect the rights and welfare of human subjects recruited to participate in research activities. The IRB has the authority to approve, require modifications in, or disapprove all research activities involving humans.

The IVI IRB is operated in accordance with the Declaration of Helsinki, International Conferences on Harmonization Good Clinical Practice (ICH GCP), Council for International Organization of Medical Sciences (CIOMS), International Ethical Guidelines for Epidemiological Studies (2009), the World Health Organization (WHO) Operating Guidelines for Ethical Review Committee that Review Biomedical Research and local Good Clinical Practice.

IVI IRB Members

Name Role in IVI IRB Job Title Affiliation
Prof. Suk-Koo Lee Chairperson Professor Samsung Medical Center, Department of Surgery
Prof. Young-Mo Koo

Senior Member

(Non Affiliated, Non Scientific)

Associate Professor Ulsan College of Medicine, Department of Medical Humanities & Social Sciences
Ms. Deborah Hong

Senior Member

(Non Scientific)

Head IVI, PR & Communications
Dr. Yae-Jean Kim

Senior Member

(Non Affiliated)

Associate Professor Samsung Medical Center, Department of Pediatrics
Dr. Vittal Mogasale Senior Member Head of PER Department IVI, Development & Delivery
Ms. Deok Ryun Kim Senior Member Research Scientist IVI, Biostatistics & Data Management, D&D
Prof. Byung-in Choe

Senior Member

(Non Affiliated, Non Scientific)

Chair Catholic University of Korea, Division of Institutional Review & Research Ethics
Ms. Yanghee Kim Senior Member Manager IVI, Clinical Operations and Quality Management, D&D
Prof. Myung Ho Oh

Senior Member

(Non Affiliated)

Professor Soonchunhyang University Chonan Hospital, Head of Neonatal Intensive Care Unit
Prof. Joon Young Song

Senior Member

(Non Affiliated)

Associate Professor Korea University Guro Hospital, Division of Infectious Disease
Ms. Sl-Ki Lim Senior Member Researcher IVI, GDAC, MERS/GDAC
Mr. Seong Ho Moon IRB Coordinator IRB Coordinator IVI, IRB/IACUC,  Finance and Operations
Dr. Samuel Teshome Senior Member Associate Research Scientist IVI, Clinical Development & Regulatory, D&D
Dr. Viliam Pavliak IRB Member Head IVI, Vaccine Process Development
Dr. Nam Seon Beck IRB Member Delivery Lead, Cholera IVI, Development & Delivery
Dr. Paola Russo

IRB Member

(Alternate)

Research Scientist IVI, Clinical Development & Regulatory, D&D

IRB Meeting Schedule (January 2018 – December 2018)

  • Regular full board meeting will be held on the last Wednesday of every month, where possible.
  • Additional meetings can be held two weeks later but no later than 4 weeks from the date that applications are received, where necessary, with approval of the IRB Chairperson and IRB Expert Secretary.
  • The applications that will need expedited or exempt review can be submitted to the IRB regardless of these dates. The review result will be delivered within 10 working days from the date that applications are received.
Months in 2018 Submission Deadline IRB Meeting Dates
January January 18 February 1
February February 6 February 22
March March 15 March 29
April April 12 April 26
May May 16 May 31
June June 14 June 28
July July 12 July 26
August August 16 August 30
September September 6 September 20
October October 11 October 25
November November 15 November 29
December December 6 December 20

Links to related sites

  1. CIMOS International conference on Revision of the 1993 CIOMOS international ethical guidelines on Biomedical Research Involving human Subjects (2002 Mar)http://www.cioms.ch
  2. Guidance for Good Clinical Practice, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use)http://www.ich.org
  3. WHO Operating Guidelines for Ethical Review Committee that Review Biomedical Researchhttp://www.searo.who.int/LinkFiles/RPC_Operational_Guidlines_Ethics.pdf
  4. Declaration of Helsinkihttp://www.wma.net/en/30publications/10policies/b3
  5. Operational Guidelines for the Establishment and Functioning of Data and Safety Monitoring Boardshttp://www.who.int/tdr/publications/tdr-research-publications/operational-guidelines/en

Contact Information

IVI IRB Office